Regulatory Affairs Manager

Job Summary:

The Regulatory Affairs Manager is responsible for ensuring that the company's products meet all regulatory requirements and standards in the markets where they are sold. This role involves managing the regulatory approval process, keeping up to date with regulatory changes, and ensuring compliance with all relevant laws and guidelines. The Regulatory Affairs Manager will also collaborate with cross-functional teams to provide guidance on regulatory issues and strategies.

Key Responsibilities:

1. Regulatory Compliance and Strategy:

2. Lead and manage regulatory submissions and ensure compliance with local regulations.

3. Develop regulatory strategies for the approval and commercialization of products or product changes.
4. Keep abreast of changing regulations and ensure the company remains in compliance with evolving regulatory environments.

5. Product Registration and Documentation:

6. Prepare, review, and submit regulatory documents, including product dossiers, to relevant regulatory agencies.

7. Coordinate with internal teams to ensure that all necessary documentation for regulatory submissions is accurate and complete.
8. Maintain regulatory files and ensure they are up to date and readily accessible.

9. Cross-functional Collaboration:

10. Work closely with marketing teams to provide regulatory input and ensure compliance is integrated into the planning.

11. Provide regulatory guidance and support to cross-functional teams, ensuring the timely and successful approval of products or product changes.
12. Assist in the preparation of marketing materials and labeling to ensure compliance with regulatory requirements.

13. Regulatory Approval Process:

14. Manage the regulatory approval process for products, product changes, and renewals, ensuring timely approvals in target markets.

15. Communicate with regulatory agencies as needed to clarify issues, respond to inquiries, or resolve regulatory concerns.

16. Risk Assessment and Compliance Monitoring:

17. Identify regulatory risks related to marketing, or distribution, and recommend mitigation strategies.

18. Monitor product performance post-market to ensure continued compliance with regulatory requirements.
19. Review and assess the impact of new or revised regulations on current and future products.

20. Regulatory Affairs Training:

21. Educate and train internal teams on regulatory affairs and compliance requirements.

22. Conduct workshops or presentations to ensure team members are aware of regulatory standards and best practices.

23. Regulatory Reporting and Documentation:

24. Maintain and track regulatory submissions and approvals, preparing status reports for senior management.

25. Prepare regulatory updates and reports for regulatory authorities, as needed.

26. Audit and Inspection Support:

27. Support internal and external audits related to regulatory compliance.

28. Participate in regulatory inspections or audits and manage the documentation and communication during such events.

Qualifications:

• Education: Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Regulatory Affairs, or a related field.
• Experience: 5+ years of experience in regulatory affairs, preferably in the relevant industry (e.g., pharmaceuticals, medical devices, direct-to-consumer).
• Knowledge: In-depth knowledge of local regulatory requirements and regulatory submission processes.

• Skills:

• Strong communication, organizational, and project management skills.

• Ability to interpret and apply regulatory guidelines and laws.
• Excellent attention to detail and ability to manage multiple priorities.
• Experience with regulatory submission software and tools.
• Ability to work cross-functionally with different departments and stakeholders.